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10.1186/s13063-019-3846-x

http://scihub22266oqcxt.onion/10.1186/s13063-019-3846-x
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31900204!6942374!31900204
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suck abstract from ncbi


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pmid31900204      Trials 2020 ; 21 (1): 8
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  • Treatment of Middle East respiratory syndrome with a combination of lopinavir/ritonavir and interferon-beta1b (MIRACLE trial): statistical analysis plan for a recursive two-stage group sequential randomized controlled trial #MMPMID31900204
  • Arabi YM; Asiri AY; Assiri AM; Aziz Jokhdar HA; Alothman A; Balkhy HH; AlJohani S; Al Harbi S; Kojan S; Al Jeraisy M; Deeb AM; Memish ZA; Ghazal S; Al Faraj S; Al-Hameed F; AlSaedi A; Mandourah Y; Al Mekhlafi GA; Sherbeeni NM; Elzein FE; Almotairi A; Al Bshabshe A; Kharaba A; Jose J; Al Harthy A; Al Sulaiman M; Mady A; Fowler RA; Hayden FG; Al-Dawood A; Abdelzaher M; Bajhmom W; Hussein MA
  • Trials 2020[Jan]; 21 (1): 8 PMID31900204show ga
  • The MIRACLE trial (MERS-CoV Infection tReated with A Combination of Lopinavir/ritonavir and intErferon-beta1b) investigates the efficacy of a combination therapy of lopinavir/ritonavir and recombinant interferon-beta1b provided with standard supportive care, compared to placebo provided with standard supportive care, in hospitalized patients with laboratory-confirmed MERS. The MIRACLE trial is designed as a recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The aim of this article is to describe the statistical analysis plan for the MIRACLE trial. The primary outcome is 90-day mortality. The primary analysis will follow the intention-to-treat principle. The MIRACLE trial is the first randomized controlled trial for MERS treatment. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02845843. Registered on 27 July 2016.
  • |Antiviral Agents/adverse effects/*therapeutic use[MESH]
  • |Coronavirus Infections/diagnosis/*drug therapy/mortality/virology[MESH]
  • |Data Interpretation, Statistical[MESH]
  • |Double-Blind Method[MESH]
  • |Drug Combinations[MESH]
  • |Host-Pathogen Interactions[MESH]
  • |Humans[MESH]
  • |Interferon beta-1b/adverse effects/*therapeutic use[MESH]
  • |Lopinavir/adverse effects/*therapeutic use[MESH]
  • |Middle East Respiratory Syndrome Coronavirus/*drug effects/pathogenicity[MESH]
  • |Multicenter Studies as Topic[MESH]
  • |Randomized Controlled Trials as Topic[MESH]
  • |Ritonavir/adverse effects/*therapeutic use[MESH]
  • |Saudi Arabia[MESH]
  • |Time Factors[MESH]


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